Rationale and design of the DEAR-OLD trial: randomized evaluation of routinely Deferred versus EARly invasive strategy in elderly patients of 75years or OLDer with non-ST-elevation myocardial infarction

4 years ago

Rationale and design of the DEAR-OLD trial: randomized evaluation of routinely Deferred versus EARly invasive strategy in elderly patients of 75years or OLDer with non-ST-elevation myocardial infarction

Comparing with conservative strategy, early invasive approach has been shown to be beneficial for initially stabilized patients with non-ST-elevation myocardial infarction (NSTEMI). However, concerns of increased risk of bleeding and other complications associated with early revascularization in patients aged ≥75years persist. A routinely deferred invasive strategy aiming to facilitate revascularization after stabilizing the culprit lesion predominate across China.

Aim

To compare efficacy and safety of deferred invasive strategy versus guideline-recommended early invasive strategy in initially stabilized Chinese patients aged ≥75years with NSTEMI.

Methods

Twenty qualified centers from ten different provinces throughout mainland China will contribute to the study. Eligible patients will be central randomized to a routine deferred invasive approach or an early invasive approach (coronary angiography >72hours or <24hours of admission and appropriate revascularization). Patients meeting the inclusion criteria but not randomized for any reason will be registered. The primary endpoint of the present study is a composite of all-cause mortality, non-lethal (re) MI, ischemic stroke and urgent revascularization at one year. Non-inferiority design is used and the inferiority margin was set to be 5%. The goal is to enroll 696 patients with expected primary endpoint rates of 30%, two-tailed α of 0.05, power of 80%, and drop-out rate of 5%.

Conclusions

the DEAR-OLD trial is a prospective, nationwide, multi-center, non-inferiority designed, open-label randomized clinical trial evaluating efficacy and safety of routinely deferred invasive strategy compared with early invasive strategy in Chinese elderly patients with NSTEMI.

Publisher URL: www.sciencedirect.com/science

DOI: S0002870317303526